Order only for patients with an established diagnosis of a BCR-ABL1 positive leukemia. This test is used to determine if a mutation is present that would interfere with response to TKI therapy in Philadelphia chromosome positive (Ph+) lymphoblastic leukemia or chronic myelogenous leukemia (CML). The test detects all common mutations, including T315I. For initial BCR-ABL1 testing, refer to BCR-ABL1, Qualitative with Reflex to BCR-ABL1 Quantitative (2005010).

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note

For specimens having no t(9;22) fusion, this test will be canceled and the ABL1 Amplification Confirmation test will be ordered.

* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

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